Phase 2 study
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Peter MacCallum Cancer Centre | East Melbourne | VIC | Not yet recruiting |
| Westmead Hospital | Westmead | NSW | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Key Inclusion Criteria:
* Life expectancy of ≥ 12 weeks in the opinion of the investigator.
* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.
* Adequate bone marrow and organ function.
* Recovered from toxicity to prior anti-cancer therapy.
Part 1 Dose Escalation cohort ONLY:
* Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations
* Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1C: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1E: Other advanced/metastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations
Part 2 Dose Optimization and Expansion cohorts ONLY:
* Part 2A: Advanced/metastatic NSCLC with KRAS non-G12C mutations and/or BRAF mutations
* Part 2A1: Advanced/metastatic NSCLC with KRAS non-G12C mutations
* Part 2A2: Advanced/metastatic NSCLC with BRAF mutations
* Part 2A3: Advanced/metastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease
* Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation
* Part 2B1: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B2: Advanced/metastatic CRC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B3: Advanced/metastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
Key Exclusion Criteria:
* Cancer that has a known MEK1/2 mutation.
* Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.
* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.
* Major surgery within 4 weeks of study entry or planned during study.
* Ongoing anticancer therapy.
* Ongoing radiation therapy.
* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.
* Clinically significant cardiovascular disease.
* Symptomatic spinal cord compression.
* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Females who are pregnant or breastfeeding.
* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
* Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.